HEADACHE and Advil

HEADACHE Symptoms and Causes

Almost everyone has had a Headache. Headache is the most common form of pain. It's a major reason people miss days at work or school or visit the doctor.

The most common type of Headache is a tension Headache. Tension Headaches are due to tight muscles in your shoulders, neck, scalp and jaw. They are often related to stress, depression or anxiety. You are more likely to get tension Headaches if you work too much, don't get enough sleep, miss meals, or use alcohol.

Other common types of Headaches include migraines, cluster Headaches, and sinus Headaches. Most people can feel much better by making lifestyle changes, learning ways to relax and taking pain relievers.

Not all Headaches require a doctor's attention. But sometimes Headaches warn of a more serious disorder. Let your health care provider know if you have sudden, severe Headaches. Get medical help right away if you have a Headache after a blow to your head, or if you have a Headache along with a stiff neck, fever, confusion, loss of consciousness, or pain in the eye or ear.

HEADACHE Clinical Trials and Studies

Treatments might be new drugs or new combinations of drugs, new surgical procedures or devices, or new ways to use existing treatments. The goal of clinical trials is to determine if a new test or treatment works and is safe. Clinical trials can also look at other aspects of care, such as improving the quality of life for people with chronic illnesses. People participate in clinical trials for a variety of reasons. Healthy volunteers say they participate to help others and to contribute to moving science forward. Participants with an illness or disease also participate to help others, but also to possibly receive the newest treatment and to have the additional care and attention from the clinical trial staff.

The primary efficacy parameters will be the percentage of cluster Headache attacks that result in the cluster Headache pain being reduced to mild or none following a single dose of 4 mg subcutaneous sumatriptan at 15 minutes and at 30 minutes.; The time meaningful relief of cluster Headache.; The percentage of attacks that produce a pain free response to a single dose of sumatriptan 4 mg subcutaneous at 15 minutes, 30 minutes and at 1 hour.; The percentage of attacks of migraine that result in resolution of all associated symptoms of cluster Headache present at the time of treatment with the study medication as well as achieving a pain free response within 1hour.; The number of patients reporting adverse effects to study medication, the type of adverse event reported and the percentage of attacks that are associate with the adverse effect.; The percentage of patients who achieve pain reduced to mild or none at 15 minutes or at 30 minutes respectively for all three treated Headache attacks.; The percentage of patients who achieve pain reduced to mild or none at 15 minutes or at 30 minutes respectively for two out of three treated Headaches.; The percentage of patients who become pain free at 15 minutes or 30 minutes or at 1 hour respectively or at any combination of the three time points for all three Headache attacks.; Patient evaluation of subcutaneous sumatriptan 4 mg regarding satisfaction with their treatment using the PPMQR assessment.; The percentage of attacks in which the pain was reduced to moderate or mild and for which the patient took a second and or a third dose of the study medication.; The percentage of attacks in which the patient became pain free at or before 1 hour and experienced a recurrence of cluster Headache and in which a second or third dose of study medication was taken.; The percentage of cluster Headaches in which the patient became free at or before 1 hour and experienced a recurrence of cluster Headache.; The mean time to meaningful pain relief across three treated Headache attacks.

The mean Headache intensity in the 10 day transitional period in the Frovatriptan group as compared to the placebo group.; The difference in mean Headache intensity between the 10 day transitional period and the baseline period.; The number of day segments with Headache of grade 6 or higher during the 10 day transitional period and during days 11-20 of the study.; Number of Headache-free days (grade zero) for first two months of study.; Proportion of patients free of medication overuse for first two months of study (i.e. less than 15 days of simple analgesic use or less than 10 days of other analgesic use per month).

Proportion of patients with significant pain reduction; Proportion of patients who are satisfied with IndoProCaf treatment; Time to significant pain reduction; Proportion of patients with significant pain reduction in case of first dose no response; Proportion of patients with significant pain reduction in case of Headache relapse; Proportion of patients who are satisfied with different medicines previously used for Headache attack

The Percent Change in the Number of Cluster Headaches per Week from Baseline to Weeks 1 through 3 of the Post-Treatment Observation Period for the Modified Intent-to-Treat Population; The Percent Change in the Number of Cluster Headaches per Week from Baseline to Weeks 1 through 3 of the Post-Treatment Observation Period for the Intent-to-Treat and Per Protocol Populations; The Percent Change in the Number of Cluster Headaches per Week from Baseline to Individual Weeks 1, 2, and 3 of the Post-Treatment Observation Period for the Modified Intent-to-Treat and the Per Protocol Populations; The Change in the Number of Cluster Headaches per Week from Baseline to Weeks 1 through 3 and to Individual Weeks 1, 2, and 3 for the Post-Treatment Observation Period for the Modified Intent-to-Treat and the Per Protocol Populations

If you think you may have a medical emergency, call your doctor or 911 immediately.

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